Twist Needle Passer Closure Device

ABSTRACT

A tissue closure device includes a needle and a suture extending therefrom, a proximal head including a proximal slot and a proximal locking mechanism for releasably engaging a first end of the needle in the proximal slot in a first configuration, and a distal head movably coupled to the proximal head so that the proximal and distal heads are movable relative to one another between an open configuration, in which a target tissue is received therebetween, and a closed configuration, in which the target tissue gripped therebetween. The distal head includes a distal slot and a distal locking mechanism for releasably engaging a second end of the needle in the distal slot in a second configuration, the needle movable between the first and second configurations by rotating the needle, the needle alternatingly passed between the proximal and distal heads to thread the suture through the target tissue.

PRIORITY CLAIM

This application claims priority to U.S. Provisional Patent ApplicationSer. No. 62/234,416 filed Sep. 29, 2015; the disclosure of which isincorporated herewith by reference.

BACKGROUND

Physicians have been increasingly willing to perform more aggressiveinterventional and therapeutic endoscopic procedures including, forexample, the removal of larger lesions (e.g., cancerous masses),tunneling under the mucosal layer of the gastrointestinal (GI) tract totreat tissue below the mucsoa, full thickness removal of tissue, thetreatment of issues of other organs by penetrating and passing out ofthe GI tract, and the endoscopic treatment/repair of post-surgicalissues (e.g., post-surgical leaks, breakdown of surgical staple lines,anastomic leaks). These procedures my increase the risk of perforatingthe wall of the GI tract, or may require closure of an opening formed inthe GI tract wall as part of the procedure. Endoscopic closure can savecosts for the hospital and provide benefits to the patient. Conventionaldevices for tissue closure may be difficult to use and time consuming incertain conditions. In addition, conventional devices may beinsufficient to close certain perforations or to treat certainconditions and anatomies such as, for example, large wounds created inthe GI tract.

SUMMARY

The present disclosure relates to a tissue closure device, comprising aneedle extending longitudinally from a first end to a second end, asuture extending from a distal end attached to the needle to a proximalend extending to a proximal end of the device, a proximal head includinga proximal slot extending longitudinally therethrough and a proximallocking mechanism for releasably engaging the first end of the needle inthe proximal slot in a first configuration, and a distal head movablycoupled to the proximal head so that the proximal and distal heads aremovable relative to one another between an open configuration, in whicha target tissue is received therebetween, and a closed configuration, inwhich the target tissue is gripped therebetween. The distal headincludes a distal slot extending longitudinally therethrough and adistal locking mechanism for releasably engaging the second end of theneedle in the distal slot in a second configuration, the needle movablebetween the first and second configurations when the proximal and distalheads are in the closed configuration by rotating the needle relative tothe proximal and distal heads, the needle alternatingly passed betweenthe proximal and distal heads to thread the suture through the targettissue.

In an embodiment, each of the proximal and distal locking mechanisms mayinclude a pair of diametrically opposed engaging structures.

In an embodiment, the pair of diametrically opposed engaging structuresof each of the proximal and distal locking mechanisms may besubstantially longitudinally aligned with one another.

In an embodiment, the pair of diametrically opposed engaging featuresmay include protrusions extending into the proximal and distal slots.

In an embodiment, the first end may include a first groove immediatelydistal of a tapering thereof and a first pair of planar surfacesextending along a portion of the first end so that the first pair ofplanar surfaces is flush with the first groove, the first grooveengagable with the proximal locking mechanism in the firstconfiguration.

In an embodiment, the second end may include a second groove immediatelyproximal of a tapering of thereof and a second pair of planar surfacesextending along a portion of the second end so that the second pair ofplanar surfaces is flush with the second groove, the second grooveengagable with the distal locking mechanism in the second configuration.

In an embodiment, the first and second pair of planar surfaces may beoffset from one another about a longitudinal axis of the needle.

In an embodiment, the distal head and the proximal head may be movablycoupled to one another via a connecting element extending proximallytherefrom to be slidably received within an opening extendinglongitudinally through the proximal head.

In an embodiment, the device may further comprise an actuating elementfor rotating the needle between the first and second configurations, theactuating element including a distal end configured to engage the firstend of the needle.

The present disclosure also relates to a system for treating a tissue,comprising an insertion device including a working channel extendingtherethrough and a closure device sized and shaped to be insertedthrough the working channel to a target site within a living body. Theclosure device includes a needle extending longitudinally from a firstend to a second end, a suture extending from a distal end attached tothe needle to a proximal end extending to a proximal end of the device,a longitudinal member extending from a proximal end to a distal end andincluding lumen extending therethrough, a proximal head attached to thedistal end of the longitudinal member, the proximal head including aproximal slot extending longitudinally therethrough and a proximallocking mechanism for releasably engaging the first end of the needle inthe proximal slot in a first configuration, a distal head movablycoupled to the proximal head so that the proximal and distal heads aremovable relative to one another between an open configuration, in whicha target tissue is received therebetween, and a closed configuration, inwhich the target tissue is gripped therebetween, the distal headincluding a distal slot extending longitudinally therethrough and adistal locking mechanism for releasably engaging the second end of theneedle in the distal slot in a second configuration, and an actuatorelement for moving the needle between the first and secondconfigurations when the proximal and distal heads are in the closedconfiguration by rotating the needle relative to the proximal and distalheads, the needle alternatingly passed between the proximal and distalheads to thread the suture through the target tissue.

In an embodiment, each of the proximal and distal locking mechanisms mayinclude a pair of diametrically opposed engaging structures.

In an embodiment, the pair of diametrically opposed engaging structuresof each of the proximal and distal locking mechanisms may besubstantially longitudinally aligned with one another.

In an embodiment, the pair of diametrically opposed engaging featuresmay include protrusions extending into the proximal and distal slots.

In an embodiment, the first end may include a first groove immediatelydistal of a tapering thereof and a first pair of planar surfacesextending along a portion of the first end so that the first pair ofplanar surfaces is flush with the first groove, the first grooveengagable with the proximal locking mechanism in the firstconfiguration. The second end may include a second groove immediatelyproximal of a tapering of thereof and a second pair of planar surfacesextending along a portion of the second end so that the second pair ofplanar surfaces is flush with the second groove, the second grooveengagable with the distal locking mechanism in the second configuration.

In an embodiment, the first and second pair of planar surfaces may beoffset from one another about a longitudinal axis of the needle.

The present disclosure also relates to a method for treating a tissuedefect, comprising inserting a device to a target area within a patientbody via a working channel of an insertion device, positioning thedevice so that a first target tissue about a periphery of a tissuedefect to be treated is received between a distal head and a proximalhead of the device, a first end of a needle releasably locked within aproximal slot in the proximal head via a proximal locking mechanism,moving the distal and proximal heads longitudinally toward one anothersuch that a second end of the needle pierces the first target tissue andthe second end of the needle is received within a distal slot extendingthrough the distal head, rotating the needle relative to the proximalhead so that the first end of the needle is unlocked from the proximalhead and the second end of the needle is releasably locked within thedistal slot via the distal locking mechanism, and moving the distal andproximal heads longitudinally away from one another such that the needleextends through the first target tissue, threading a suture attached tothe needle through the first target tissue.

BRIEF DESCRIPTION

FIG. 1 shows a perspective view of a system according to an exemplaryembodiment;

FIG. 2 shows a longitudinal side view of a device according to thesystem of FIG. 1;

FIG. 3 shows a perspective view of the device of FIG. 1;

FIG. 4 shows a perspective view of a portion of the device of FIG. 1;

FIG. 5 shows a longitudinal cross-sectional view of the device of FIG.1, in an open configuration with a needle locked via a proximal lockingmechanism;

FIG. 6 shows a longitudinal cross-sectional view of the device of FIG.1, in a closed configuration with the needle locked via the proximallocking mechanism;

FIG. 7 shows a longitudinal cross-sectional view of the device of FIG.1, in the closed configuration with the needle locked via a distallocking mechanism;

FIG. 8 shows a longitudinal cross-sectional view of the device of FIG.1, in the open configuration with the needle locked via the distallocking mechanism;

FIG. 9 shows a perspective view of a needle of the device of FIG. 1; and

FIG. 10 shows a perspective view of an actuator element of the device ofFIG. 1.

DETAILED DESCRIPTION

The present disclosure may be further understood with reference to thefollowing description and the appended drawings, wherein like elementsare referred to with the same reference numerals. The present disclosureis directed to devices for the treatment of tissue and, in particularendoscopic tissue treatment devices. Exemplary embodiments of thepresent disclosure describe a system for passing a needle and suturethrough target tissue between proximal and distal heads of a device totreat a tissue defect such as, for example, a tissue opening. Inparticular, the needle is passed longitudinally through the targettissue alternatingly between proximal and distal heads of the device tobe threaded along about a periphery of the tissue defect. The needle isalternatingly locked to the proximal and distal heads by rotating theneedle relative thereto. Once the needle and suture have been threadedabout the entire tissue defect in a desired pattern, the suture may betensioned to cinch the tissue defect to a closed configuration. Itshould be noted that the terms “proximal” and “distal” are intended torefer to a direction toward (proximal) and away from (distal) a user ofthe device.

As shown in FIGS. 1-10, a tissue closure system 100 according to anexemplary embodiment of the present disclosure comprises a flexibleclosure device 102 sized and shaped for insertion through an insertiondevice 170 (e.g., through a working channel of a flexible endoscope) toa target area within a living body to pass a needle 104 and suture 106through a tissue extending about a periphery 12 of a tissue defect 10 tocinch the tissue defect 10 closed. The closure device 102 includes alongitudinal member 108 and a distal head 110 longitudinally movablerelative thereto. A distal end 114 of the longitudinal member 108includes a proximal head 116 mounted or attached thereto such thattarget tissue may be received in a space 112 between the distal andproximal heads 110, 116. The needle 104 is passed between the proximalhead 116 and the distal head 110 to thread the suture 106 about theperiphery of the tissue defect. The proximal head 116 includes aproximal locking mechanism 118 for releasably locking a first end 122 ofthe needle 104 in a first configuration while the distal head 110includes a distal locking mechanism 120 for releasably locking a secondend 124 of the needle 104 in a second configuration. The needle 104 maybe alternatingly moved between the first and second configurations byrotating the needle 104 about a longitudinal axis thereof, relative tothe longitudinal member 108, via an actuating element 130.

In the first configuration, the needle 104 is engaged to the proximalhead 116 and may be inserted through the target tissue received withinthe space 112 by moving the distal head 110 toward the proximal head116. The proximal movement of the distal head 110 relative to theproximal head 116 pushes the tissue proximally against the needle 104pushing the needle 104 through the target tissue from a proximal surfaceof the target tissue to the distal surface. As the distal head 110 ismoved toward the proximal head 116, the second end 124 of the needle 104is received within the distal locking mechanism 120. The needle 104 isthen rotated relative to the longitudinal member 108 and the distal head110, so that the needle 104 is released from the proximal lockingmechanism 118 and moved to the second configuration engaging the distallocking mechanism 120. The distal head 110 may then be moved distallyrelative to the proximal head 116 to draw the suture 106 which isattached to the needle 104, through the target tissue. The closuredevice 102 may then be repositioned along the periphery of the tissuedefect so that an adjacent portion of the target tissue along theperiphery of the tissue defect is received within the space 112. Thedistal head 110 may once again be moved toward the proximal head 116 sothat the needle 104 and the suture 106 may be passed through theadjacent portion of the target tissue in a movement which is similaralthough directed this time from proximal to distal. Once the needle 104is received again within the proximal locking mechanism 118, the needle104 is rotated to release the needle 104 from the distal lockingmechanism 120 and engage the needle 104 to the proximal lockingmechanism 118, moving the closure device 102 to the first configuration.Moving the device 102 to a new position along the periphery of thetissue defect to the next location through which the needle 104 is to beinserted draws the suture 106 through the tissue. This process may berepeated by repositioning the closure device 102 and alternatinglymoving the needle 104 between the first and second configurations untilthe entire periphery of the tissue defect has been threaded via thesuture 106. Once the entire periphery of the suture 106 has beenthreaded through the desired number of locations adjacent to the tissuedefect, the needle 104 is released from the closure device 102 to act asan anchor. The suture 106 may then be tensioned to draw edges of thetissue defect together, cinching the tissue defect closed.

The longitudinal member 108 extends longitudinally from a proximal end(not shown) to the distal end 114 and includes a lumen 136 extendingtherethrough. In one embodiment, the proximal head 116 may be attachedor mounted to the distal end 114 of the longitudinal member 108. Inanother embodiment, the proximal head 116 may be integrally formedtherewith. The proximal head 116 includes a slot 126 extendinglongitudinally therein, the slot 126 sized and shaped to receive thefirst end 122 of the needle 104. The slot 126 may, for example, extendthrough an entire length of the proximal head 116. The proximal lockingmechanism 118 may be configured as a pair of diametrically opposedprotrusions 128 extending laterally into the slot 126 for engaging aportion of the needle 104 in the first configuration. The longitudinalmember 108 may also include a longitudinal groove 132 extending along anexterior surface 134 thereof for receiving a portion of the suture 106therein. The suture 106 may extend along the groove 132.

The distal head 110 is movably coupled to the longitudinal member 108via a connecting element 138 extending proximally therefrom. Theconnecting element 138 may be slidably received through an opening 140extending through the proximal head 116 and through the lumen 136 of thelongitudinal member 108 to a proximal end accessible to a user so thatthe connecting element 138 may be moved longitudinally relative to thelongitudinal member 108 to move the distal head 110 toward and away fromthe proximal head 116. In particular, moving the connecting element 138distally relative to the longitudinal member 108 moves the distal head110 distally away from the proximal head 116, increasing the space 112between the distal and proximal heads 110, 116. Moving the connectingelement 138 proximally relative to the longitudinal member 108 draws thedistal head 110 proximally toward the proximal head 116, decreasing thespace 112 between the distal and proximal heads 110, 116.

Similarly to the proximal head 116, the distal head 110 includes a slot144 extending longitudinally therein, the slot 144 sized and shaped toreceive the second end 124 of the needle 104 therein. The slot 144according to this embodiment extends, for example, through an entirelength of the distal head 110. The distal locking mechanism 120 may beconfigured as a pair of diametrically opposed protrusions 146 extendinglaterally into the slot 144 to engage a portion of the needle 104 in thesecond configuration. The slot 126 in the proximal head 116 and the slot144 in the distal head 110 may be aligned with one another (e.g., extendcoaxially) so that the needle 104 may be alternatingly received and/orlocked within the slots 126, 144, as will be described in further detailbelow. Corresponding opposing protrusions 128, 146 of the proximal anddistal heads 116, 110, respectively, may also be aligned with oneanother. Each of the proximal and distal heads 116, 110 may also includetissue grabbing features such as, for example, teeth 164, 166,respectively, for gripping tissue that is received within the space 112therebetween.

The needle 104 extends longitudinally from the first end 122 to thesecond end 124. Each of the first and second ends 122, 124 is tapered sothat the ends 122, 124 may pierce tissue as the needle 104 is passedbetween the proximal and distal heads 116, 110. The needle 104 may alsoinclude a hole 156 extending laterally therethrough for attaching thesuture 106 to the needle 104. The hole 156 may extend through, forexample, a point along a length of the needle 104 equidistant from thefirst and second ends 122, 124. The hole 156 may, however, extendlaterally through any portion of the needle 104 so long as a distal endof the suture 106 may be passed therethrough to attach the suture 106 tothe needle 104. In particular, the suture 106 may be passed through thehole 156 and knotted to prevent the distal end of the suture 106 frombeing disengaged therefrom.

Immediately distal of the tapered first end 122, the needle 104 includesa first circumferential groove 148 extending thereabout. The taperedfirst end 122, however, also includes a pair of planar surfaces 150 (seeFIGS. 7-9) extending therealong, each of the planar surfaces 150extending on opposite sides of one another along the first end 122 sothat the first groove 148 is flush with portions of the first end 122along which the planar surfaces 150 extend. Thus, in a first position,in which the planar surfaces 150 of the needle 104 are aligned with(e.g., facing toward) the pair of protrusions 128 within the slot 126 ofthe proximal head 116, the first end 122 of the needle 104 is slidablewithin the slot 126 as the planar surfaces 150 and the first groove 148do not engage the protrusions 128. In a second position, however, inwhich the needle 104 is rotated approximately 90 degrees about alongitudinal axis thereof, the first groove 148 engages the pair ofprotrusions 128, locking the first end 122 of the needle 104 in theproximal head 116.

Similarly, immediately proximal of the tapered second end 124, theneedle 104 includes a second circumferential groove 152 extendingthereabout. The tapered second end 124 also includes a pair of planarsurfaces 154 extending therealong, each of the planar surfaces 154extending on opposite sides of one another along the second end 124 sothat the second groove 152 is flush with portions of the second end 124along which the planar surfaces 154 extend. The planar surfaces 154 ofthe second end 124 may be offset from the planar surfaces 150 of thefirst end 122 by approximately 90 degrees so that, when the needle is inthe first position, as described above, the first end 122 is slidable(e.g., unlocked) within the slot 126 of the proximal head 116, butlocked within the slot 142 of the distal head 110. In other words, inthe first position, the protrusions 146 of the distal head 110 engagethe second groove 152. When the needle 104 is rotated about thelongitudinal axis thereof, to the second position, the planar surfaces154 are moved toward the protrusions 146 so that the second groove 152disengages the protrusions 146, unlocking the needle 104 with respect tothe distal head 110.

Although the exemplary embodiment shows and describes protrusions 128,146 in the proximal and distal heads 116, 110, respectively, which arealigned with one another and planar surfaces 150, 154 along first andsecond ends 122, 124 of the needle 104, respectively, that are offsetfrom one another, in another embodiment, the protrusions 128, 146 may beoffset while the planar surfaces 150, 154 are aligned. The proximal anddistal locking mechanisms 118, 120 may include any of a variety ofconfigurations so long as rotating the needle 104 relative to thelongitudinal member 108 moves the closure device 102 between the firstand second configurations. For example, in another embodiment, theproximal and distal locking mechanisms may include recesses configuredto receive correspondingly shaped protrusions or projections of theneedle 104.

The needle 104 may be rotated relative to the longitudinal member 108via the actuator element 130, which is housed within the lumen 136 ofthe longitudinal element 108. The actuator element 130 extendslongitudinally from a distal end 158 housed within a portion of theproximal head 116 to a proximal end 160, which is connected to aproximal end of the closure device 102 to be accessible to a user of theclosure device 102. The distal end 158 includes a recess 162 extendinglongitudinally thereinto, the recess 162 sized and shaped to receive thefirst end 122 of the needle 104 therein, when the first end 122 isreceived within the slot 126 of the proximal head 116. In particular,the first end 122 and the recess 162 are keyed to one another so that,when the first end 122 of the needle 104 is received therein, arotational movement of the actuator element 130 results in a rotation ofthe needle 104 relative to the longitudinal member 108.

The closure system 100, as described above, may be used to treat fullthickness perforations, in which a perforation or opening 10 existsthrough all four tissue layers (mucosa, submucosa, muscularis, andserosa), along with perforations that extend through the mucosa and/orsubmucosa or through any tears or perforations through less than thefull thickness of the organ as would be understood by those skilled inthe art.

According to a first surgical technique for treating full thicknessperforations using the closure system 100, the closure device 102 may beinserted through the insertion device 170 so that the distal head 110 isinserted through the tissue defect 10 to be treated. The closure device102 may be inserted through the insertion device 170 in the firstconfiguration, so that the needle 104 is engaged to the proximal head116. The closure device 102 is positioned so that a first target tissuealong the periphery 12 of the tissue defect 10 is received between thespace 112 between proximal and distal heads 116, 110 of the closuredevice. Once the first target tissue has been received within the space112, the proximal and distal heads 116, 110 are moved toward one anotherso that the second end 124 of the needle 104 pierces the first targettissue received within the space 112 and is received within the slot 144of the distal head 110. Using the actuator 130, the user rotates theneedle 104 to move the closure device 102 to the second configuration,in which the needle 104 is disengaged from the proximal lockingmechanism 118 and locked via the distal locking mechanism 120. Theneedle 104 may be rotated approximately 90 degrees about thelongitudinal axis thereof. In one embodiment, rotation of the needle 104causes the groove 148 adjacent the first end 122 to disengageprotrusions 128 within the slot 126 of the proximal head 116 whilecausing the groove 152 adjacent the second end 124 to engage theprotrusions 146 within the slot 144 of the distal head 110. Upon lockingthe needle 103 to the distal head 110 may be moved distally away fromthe proximal head 116 so that the needle 104 is passed to a distal sideof the first target tissue, thereby threading the suture 106 through thefirst portion of target tissue.

The closure device 102 may then be positioned along a second targettissue along the periphery 12 of the tissue defect so that the secondtarget tissue is received within the space 112. The second target tissuemay, for example, be along a side of the tissue defect opposite thefirst target tissue. Upon positioning the second target tissue withinthe space 112, the distal head 110 may then be drawn proximally towardthe proximal head 116 so that the first end 122 of the needle 104pierces the second target tissue and is received within the slot 126 ofthe proximal head 116. The needle 104 may then be again rotatedapproximately 90 degrees, via the actuator element 130, so that theneedle 104 is moved from the second configuration, in which it is lockedvia the distal locking mechanism 120, to the first configuration, inwhich the needle 104 is disengaged from the distal locking mechanism 120to be locked via the proximal locking mechanism 118. Thus, when thedistal head 110 is moved away from the proximal head 116, the needle 104remains locked to the proximal head 116 so that the needle 104 passesthrough the second target tissue to a proximal side thereof, therebythreading the suture 106 therethrough.

The above-described steps may be repeated at different locations alongthe periphery 12 of the tissue defect 10 until the suture 106 has beenthreaded along a length of the tissue defect 12. In one embodiment, thesteps may be alternatingly repeated along opposing sides of the tissuedefect 10. It is not required, however, for the suture 106 to bethreaded through alternating sides of the tissue defect 10. In anotherembodiment, the suture 106 may be threaded about the periphery 12 of thetissue defect in a circumferential manner. Once the suture 106 has beenthreaded along the tissue defect 10, as desired, the needle 104 may bereleased from either the proximal head 116 to act as an anchor at aposition of the last thread. Tensioning of the suture 106 will cause theneedle 104 to contact a surface of a portion of tissue along theperiphery 10 of the tissue defect 10 to prevent the suture 106 frombeing unthreaded therefrom and will draw edges of the tissue defect 10toward one another to close the tissue defect 10. Once the tissue defect10 has been closed as desired, a cinch (not shown) may be moved along alength of the suture 106 until the cinch contacts a surface of thetissue through which the suture 106 extends. The cinch will hold thetissue defect in the closed position.

According to another embodiment, a method for sealing mucosal layers oftissue may be substantially similar to the full thickness proceduredescribed above. Rather than placing the distal head 110 through atissue defect to extend distally past a serosa layer of the tissue, thedistal head 110 may be placed between the mucosa and submucosa layers ofthe tissue so that the suture 106 is passed through the mucosa layer ina desired pattern about a perforation to be treated.

According to yet another embodiment, a method for sealing the mucosaland submucal layers of tissue may be substantially similar to the fullthickness procedure described above. Rather than inserting the distalhead 110 through a tissue defect to extend distally past a last serosalayer of tissue, however, the distal head 110 remains within a lumen of,for example, a GI tract into which the closure device 102 is inserted,at all times. The closure device 102 may be positioned so that aproximal surface of a first target tissue along a tissue defect to betreated is positioned adjacent the space 112. Thus, when the distal head110 is moved toward the proximal head 116, the distal and proximal heads110, 116 grip the first target tissue therebetween to from a lump oftissue through which the second end 124 of the needle 104 is pierced.The needle 104 is then rotated to move the needle 104 from the firstconfiguration to the second configuration, locking the needle 104 to thedistal head 110 and disengaging the needle 104 from the proximal head116. The distal head 110 may then be moved away from the proximal head116, the needle 104 remaining locked to the distal head 110 so that theneedle 104 passes through the first target tissue such that the suture106 is threaded therethrough.

The closure device 102 may then be positioned so that the space 112 ispositioned adjacent a proximal surface of a second target tissue along aperiphery of a tissue defect to be treated. The second target tissue mayextend along a side of the tissue defect opposition the first targettissue. Drawing the distal head 110 toward the proximal head 116 willcause the second target tissue to be gripped between the distal andproximal heads 110, 116 in the form of a lump so that the first end 122of the needle pierces the second target tissue and is received withinthe proximal head 116. The needle 104 is then rotated so that the needle104 is moved from the second configuration to the first configuration,disengaging the distal head 110 to be locked within the proximal head116. Thus, moving the distal head 110 away from the proximal head 116causes the needle 110 to be passed through the second target tissue sothat the suture 106 is threaded therethrough.

The above-described steps may be repeated at different locations alongthe periphery of the tissue defect until the suture 106 has beenthreaded along the tissue defect in a desired pattern. Similarly to thefull thickness procedure described above, once the desired suturepattern has been achieved, the needle 104 may be released from theproximal head 116, by rotating the needle 104 relative thereto. Thesuture 106 is then tensioned so that the needle 104 may act as an anchorwhile the edges of the tissue defect are drawn together to close thetissue defect. A cinch may be applied over the suture 106 to hold thetissue defect in the closed position.

Although the exemplary methods and procedures describe inserting theclosure device 102 to the target area with the needle 104 in the firstconfiguration (i.e., locked to the proximal head 116), the closuredevice 102 may be similarly inserted to the target area with the needle104 in the second configuration. The suture 106 will simply initiallypassed through the target tissue in an opposing direction. The closuredevice 102 may be otherwise utilized in a similar manner.

Variations may be made in the structure and methodology of the presentdisclosure, without departing from the spirit and the scope of thedisclosure. Thus, it is intended that the present disclosure cover themodifications and variations of this disclosure that may be contemplatedby a person of skill in the art.

1-15. (canceled)
 16. A tissue closure device, comprising: a needleextending longitudinally from a first end to a second end; a sutureextending from a distal end attached to the needle to a proximal endextending to a proximal end of the device; a proximal head including aproximal slot extending longitudinally therethrough and a proximallocking mechanism for releasably engaging the first end of the needle inthe proximal slot in a first configuration; and a distal head movablycoupled to the proximal head so that the proximal and distal heads aremovable relative to one another between an open configuration, in whicha target tissue is received therebetween, and a closed configuration, inwhich the target tissue is gripped therebetween, the distal headincluding a distal slot extending longitudinally therethrough and adistal locking mechanism for releasably engaging the second end of theneedle in the distal slot in a second configuration, the needle movablebetween the first and second configurations when the proximal and distalheads are in the closed configuration by rotating the needle relative tothe proximal and distal heads, the needle alternatingly passed betweenthe proximal and distal heads to thread the suture through the targettissue.
 17. The device of claim 16, wherein each of the proximal anddistal locking mechanisms includes a pair of diametrically opposedengaging structures.
 18. The device of claim 17, wherein the pair ofdiametrically opposed engaging structures of each of the proximal anddistal locking mechanisms are substantially longitudinally aligned withone another.
 19. The device of claim 17, wherein the pair ofdiametrically opposed engaging features include protrusions extendinginto the proximal and distal slots.
 20. The device of claim 16, whereinthe first end includes a first groove immediately distal of a taperingthereof and a first pair of planar surfaces extending along a portion ofthe first end so that the first pair of planar surfaces is flush withthe first groove, the first groove engagable with the proximal lockingmechanism in the first configuration.
 21. The device of claim 20,wherein the second end includes a second groove immediately proximal ofa tapering of thereof and a second pair of planar surfaces extendingalong a portion of the second end so that the second pair of planarsurfaces is flush with the second groove, the second groove engagablewith the distal locking mechanism in the second configuration.
 22. Thedevice of claim 21, wherein the first and second pair of planar surfacesare offset from one another about a longitudinal axis of the needle. 23.The device of claim 16, wherein the distal head and the proximal headare movably coupled to one another via a connecting element extendingproximally therefrom to be slidably received within an opening extendinglongitudinally through the proximal head.
 24. The device of claim 16,further comprising an actuating element for rotating the needle betweenthe first and second configurations, the actuating element including adistal end configured to engage the first end of the needle.
 25. Asystem for treating a tissue, comprising: an insertion device includinga working channel extending therethrough; and a closure device sized andshaped to be inserted through the working channel to a target sitewithin a living body, the closure device including: a needle extendinglongitudinally from a first end to a second end; a suture extending froma distal end attached to the needle to a proximal end extending to aproximal end of the device; a longitudinal member extending from aproximal end to a distal end and including lumen extending therethrough;a proximal head attached to the distal end of the longitudinal member,the proximal head including a proximal slot extending longitudinallytherethrough and a proximal locking mechanism for releasably engagingthe first end of the needle in the proximal slot in a firstconfiguration; a distal head movably coupled to the proximal head sothat the proximal and distal heads are movable relative to one anotherbetween an open configuration, in which a target tissue is receivedtherebetween, and a closed configuration, in which the target tissue isgripped therebetween, the distal head including a distal slot extendinglongitudinally therethrough and a distal locking mechanism forreleasably engaging the second end of the needle in the distal slot in asecond configuration; and an actuator element for moving the needlebetween the first and second configurations when the proximal and distalheads are in the closed configuration by rotating the needle relative tothe proximal and distal heads, the needle alternatingly passed betweenthe proximal and distal heads to thread the suture through the targettissue.
 26. The system of claim 25, wherein each of the proximal anddistal locking mechanisms includes a pair of diametrically opposedengaging structures.
 27. The system of claim 26, the pair ofdiametrically opposed engaging structures of each of the proximal anddistal locking mechanisms being substantially longitudinally alignedwith one another.
 28. The system of claim 26, wherein the pair ofdiametrically opposed engaging features include protrusions extendinginto the proximal and distal slots.
 29. The system of claim 28, whereinthe first end includes a first groove immediately distal of a taperingthereof and a first pair of planar surfaces extending along a portion ofthe first end so that the first pair of planar surfaces is flush withthe first groove, the first groove engagable with the proximal lockingmechanism in the first configuration, and wherein the second endincludes a second groove immediately proximal of a tapering of thereofand a second pair of planar surfaces extending along a portion of thesecond end so that the second pair of planar surfaces is flush with thesecond groove, the second groove engagable with the distal lockingmechanism in the second configuration.
 30. The system of claim 29,wherein the first and second pair of planar surfaces are offset from oneanother about a longitudinal axis of the needle.
 31. A method fortreating a tissue defect, comprising: inserting a device to a targetarea within a patient body via a working channel of an insertion device;positioning the device so that a first target tissue about a peripheryof a tissue defect to be treated is received between a distal head and aproximal head of the device, a first end of a needle releasably lockedwithin a proximal slot in the proximal head via a proximal lockingmechanism; moving the distal and proximal heads longitudinally towardone another such that a second end of the needle pierces the firsttarget tissue and the second end of the needle is received within adistal slot extending through the distal head; rotating the needlerelative to the proximal head so that the first end of the needle isunlocked from the proximal head and the second end of the needle isreleasably locked within the distal slot via the distal lockingmechanism; and moving the distal and proximal heads longitudinally awayfrom one another such that the needle extends through the first targettissue, threading a suture attached to the needle through the firsttarget tissue.
 32. The method of claim 31, further comprising:positioning the device so that a second target tissue about theperiphery of the tissue defect to be treated is received between thedistal and proximal heads; moving the distal and proximal headslongitudinally toward one another such that the first end of the needleis pierces the second target tissue and the first end of the needle isreceived within the proximal slot of the proximal head; rotating theneedle so that the second end of the needle unlocks from the distal headand is locked within the proximal slot via the proximal lockingmechanism; and moving the distal and proximal heads longitudinally awayfrom one another such that the needle extends through the second targettissue, threading the suture through the second portion of the targettissue.
 33. The method of claim 32, wherein each of the proximal anddistal locking mechanisms include a pair of diametrically opposedprotrusions extending into each of the proximal and distal slots. 34.The method of claim 32, wherein the first end includes a first grooveimmediately distal of a tapering thereof and a first pair of planarsurfaces extending along a portion of the first end so that the firstpair of planar surfaces is flush with the first groove, the first grooveengagable with the proximal locking mechanism in the firstconfiguration, and wherein the second end includes a second grooveimmediately proximal of a tapering of thereof and a second pair ofplanar surfaces extending along a portion of the second end so that thesecond pair of planar surfaces is flush with the second groove, thesecond groove engagable with the distal locking mechanism in the secondconfiguration
 35. The method of claim 31, further comprising tensioningthe suture to draw the first and second portions of the target tissuetoward one another to move the tissue defect toward a closedconfiguration.